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GAMP5 Process Control System Validation

Paris Control Systems has extensive experience validating control systems for the pharmaceutical industry to ensure compliance with stringent quality assurance requirements. They adopt standards from organizations like GAMP, ISA, FDA, and MHRA. Paris Control Systems follows a life cycle model for design, build, and verification on pharmaceutical projects and can provide independent testing and validation services.

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0% found this document useful (0 votes)
171 views1 page

GAMP5 Process Control System Validation

Paris Control Systems has extensive experience validating control systems for the pharmaceutical industry to ensure compliance with stringent quality assurance requirements. They adopt standards from organizations like GAMP, ISA, FDA, and MHRA. Paris Control Systems follows a life cycle model for design, build, and verification on pharmaceutical projects and can provide independent testing and validation services.

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krisna8154
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Validation & Testing Services

The pharmaceutical industry has stringent validation and quality assurance requirements
to which all control system software must comply before it can be deployed on active plant.
Paris Control Systems has extensive experience and expertise in validating control
systems for the pharmaceutical industry.
All our engineering and software development for the pharmaceutical industry is compliant with
the QA requirements dictated by the Medicines and Healthcare products Regulatory Agency
(MHRA) and, where appropriate, the American Food and Drug Administration (FDA). We adopt
the standards and recommended practices required by the pharmaceutical industry as follows:
GAMP 5 Good Automated Manufacturing Practice
ANSI/ISA-88 standards for Batch Control
ANSI/ISA-95 standards for Control System Integration
ANSI/ISA-99 standards for Control System Security
All pharmaceutical projects implemented by Paris Control Systems follow the standard Life Cycle
Model for design, build and verification required under the Good Automated Manufacturing
Practice guide lines:

Paris Control Systems has its own quality procedures and is able to undertake all aspects of the
Life Cycle Model. We are also able to provide independent testing and validation of third party
control systems (either new build, or existing plant).
http://www.pariscontrols.co.uk/services04Val.html

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